President Donald Trump said part of the reason he doesn’t regularly wear a mask is “everyone’s tested” before they see him. But multiple studies have raised questions about the accuracy of a coronavirus test the White House has used, and the Food and Drug Administration has received dozens of reports of potential problems with that test.
The federal government also continues to distribute thousands of the rapid coronavirus tests made by Abbott Laboratories each week throughout the country, spending what adds up to hundreds of millions of dollars on them, all while questions about the test’s accuracy have mounted and some states are urging precautions for health care providers using them.
Abbott’s point-of-care “ID NOW COVID-19” test, which was promoted by Trump at the White House, produces results in minutes rather than hours and is portable enough to be used in mobile testing sites and rural regions that lack easy access to labs.
Yet studies have raised doubts about the Abbott device’s accuracy. Abbott has disputed those findings and pointed to other studies with more favorable results, but a spokesperson for the FDA told CNN on Wednesday that the agency has received a total of 126 reports of “adverse events” about the ID NOW test. There are three other point-of-care tests authorized by the FDA, but the agency has not received any adverse event reports for those, the FDA spokesperson said.
In May, the FDA announced “possible accuracy concerns” with the device and said it had received 15 adverse event reports. The FDA this week did not specify the contents of all the adverse event reports, but in a statement to CNN, an Abbott spokesperson said the company has shared reports about false negatives with the FDA, meaning instances when tests show patients are not infected with Covid-19 when they are actually positive for the disease. Abbott also said the adverse events it is required to report are a small fraction of the tests that have been performed.
Despite such concerns raised in recent months, an office within the Department of Health and Human Services has signed contracts totaling more than $200 million to purchase Abbott’s rapid test, according to contract data. That includes a $174 million contract signed on June 4 that said the agency “has a requirement to purchase” the tests.
A spokesperson for HHS did not respond to a question about the details of that requirement but said in a statement that HHS, including the FDA, is closely monitoring the efficacy of the ID NOW tests and working with Abbott on follow-up studies.
“We do believe Abbott positive tests are accurate and that the Abbott test remains critically important and accurate when used as directed especially for remote areas and during outbreak investigations. At this time we are not recommending to end the use of Abbott test devices or tests,” the HHS spokesperson said.
An Abbott spokesperson said the test is delivering reliable results, that the company has delivered 4.3 million ID NOW tests to all states and that the rate of false negative complaints is 0.015%.
HHS has been distributing tests for the devices throughout the country since it initially became available, but some states are urging caution.
Ten state health agencies told CNN they specifically recommend or require that individuals who test negative on the Abbott rapid device be retested, and most recommended using a different, slower, more reliable method for diagnosing Covid-19, known as lab-based “polymerase chain reaction” or PCR tests.
Other states said they have pointed health care providers to the instructions for the ID NOW posted on the FDA’s website, which state that negative results “should be treated as presumptive,” and if patients show signs and symptoms of the virus, they should then be tested with different authorized tests.
Vermont’s commissioner of health, Dr. Mark Levine, decided not to give the Abbott rapid devices received from the federal government to hospitals in the state due to the FDA’s update on possible accuracy concerns, according to a spokesperson for the state’s Health Department.
A Wisconsin Department of Health Services spokesperson told CNN that the ID NOW tests are used in different locations in the state but that “We have urged caution when using these instruments.”
Other states have found the Abbott tests useful. A spokesperson for the Rhode Island Department of Health, Joseph Wendelken, said the Abbott rapid test has been “enormously beneficial” and has enabled the state to quickly identify thousands of positive cases and get those individuals and their recent contacts into quarantine.
But Wendelken also said the Rhode Island COVID-19 Testing and Validation Task Force reviewed studies on the ID NOW and recommended phasing out the state’s use of it.
He described the test as “a little less sensitive than other tests,” and said, “For that reason, we decided strategically to be less reliant on Abbott ID Now tests as other, more sensitive tests came onto the market.”
Dr. Mark Pandori, director of the Nevada State Public Health Laboratory, which receives ID NOW tests from HHS and disperses them in the state, said that while there has been some concern over the test’s quality, other data show the test performs well.
He said the test must be performed exactly as the manufacturer has instructed, and although such point-of-care tests typically do not perform as well as lab-based tests, he said they serve a purpose.
“The convenience and power of being able to run the test so conveniently is considered against the slightly lower performance factors,” Pandori said.
In April, Abbott warned that its device can produce false negatives if a special solution – known as “viral transport media” – is used to move or store patients’ samples. The company said customers should instead only place swabs with patient samples directly in the device.
The FDA posted its alert about the Abbott test in May after researchers at NYU Langone Health in New York released a study that found the test missed between a third and about half of infectious samples identified as positive by another point-of-care test by the company Cepheid. While the ID NOW delivers results within 13 minutes, the Cepheid test delivers them within 45 minutes.
The authors of the study acknowledged it has limitations, including its small sample size, but said the Abbott test was “unacceptable” for use with their patients.
Abbott has argued that study was “flawed” due to two different sample collection techniques, no tiebreaker test for discrepancies and a population that included patients with low viral levels who were tested more than two weeks after they first developed symptoms. A spokesperson for NYU Langone Health said they stand by the study’s findings.
In a statement, Abbott shared links to other studies that have found higher accuracy rates, and said, “ID NOW is delivering reliable results on the frontlines of this pandemic with accuracy rates in some studies as high as 94.7%”
But additional studies have found differing results. An evaluation from Northwell Health, for example, found that the Abbott rapid test missed 12.3% of positive cases. Research from Columbia University Irving Medical Center concluded that the ID NOW correctly identified only 73.9% of infectious samples compared with another test.
Scott Becker, the CEO of the Association of Public Health Laboratories, which represents state and local public labs, said he is waiting for additional guidance from the FDA on the ID NOW to better understand the test’s performance.
Becker said that in light of the emergency of coronavirus, he thinks HHS did the responsible thing by procuring a point-of-care diagnostic for states that had been authorized by the FDA, but he said emerging data must be considered in future decision-making.
“Until we get the results of new information from FDA and Abbott, I think there will be this dichotomy,” Becker said, referring to differing assessments and approaches to using the test. “Right now, we need all the tools that we can get our hands on, but they have to be tools that work.”